Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial (Cereal)

The University of Texas System (UT)

Status: Terminated

Conditions: Labor, Premature

Treatments: Procedure: Early Artificial rupture of membranes; Procedure: Delayed Artificial rupture of membranes

Study type: Interventional

Funder types: Other

Identifiers

NCT03682822

HSC-MS-18-0511

Details and patient eligibility

About

To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.

Full description

Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.

Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.

The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.

Enrollment: 104 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
• Fetus in the cephalic position
• Intent to induce labor for vaginal delivery
• If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.

Exclusion criteria

• Preterm premature rupture of membranes (PPROM)
• Fever or suspected chorioamnionitis prior to start of IOL
• Prior uterine scar
• Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
• Intrauterine fetal demise
• Major fetal anomaly
• Cervical dilation > 4 cm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Early artificial rupture of membranes

Experimental group

Description:

Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.

Treatment:

Procedure: Early Artificial rupture of membranes

Delayed artificial rupture of membranes

Active Comparator group

Description:

Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.

Treatment:

Procedure: Delayed Artificial rupture of membranes